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      A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study

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          Abstract

          Background

          Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high—25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions.

          Objective

          The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care.

          Methods

          Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period.

          Results

          Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls.

          Conclusions

          The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens.

          Trial Registration

          ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno)

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          Most cited references30

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          ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM).

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            Impact of medication adherence on hospitalization risk and healthcare cost.

            The objective of this study was to evaluate the impact of medication adherence on healthcare utilization and cost for 4 chronic conditions that are major drivers of drug spending: diabetes, hypertension, hypercholesterolemia, and congestive heart failure. The authors conducted a retrospective cohort observation of patients who were continuously enrolled in medical and prescription benefit plans from June 1997 through May 1999. Patients were identified for disease-specific analysis based on claims for outpatient, emergency room, or inpatient services during the first 12 months of the study. Using an integrated analysis of administrative claims data, medical and drug utilization were measured during the 12-month period after patient identification. Medication adherence was defined by days' supply of maintenance medications for each condition. The study consisted of a population-based sample of 137,277 patients under age 65. Disease-related and all-cause medical costs, drug costs, and hospitalization risk were measured. Using regression analysis, these measures were modeled at varying levels of medication adherence. For diabetes and hypercholesterolemia, a high level of medication adherence was associated with lower disease-related medical costs. For these conditions, higher medication costs were more than offset by medical cost reductions, producing a net reduction in overall healthcare costs. For diabetes, hypercholesterolemia, and hypertension, cost offsets were observed for all-cause medical costs at high levels of medication adherence. For all 4 conditions, hospitalization rates were significantly lower for patients with high medication adherence. For some chronic conditions, increased drug utilization can provide a net economic return when it is driven by improved adherence with guidelines-based therapy.
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              Predictive validity of a medication adherence measure in an outpatient setting.

              This study examines the psychometric properties and tests the concurrent and predictive validity of a structured, self-reported medication adherence measure in patients with hypertension. The authors also assessed various psychosocial determinants of adherence, such as knowledge, social support, satisfaction with care, and complexity of the medical regimen. A total of 1367 patients participated in the study; mean age was 52.5 years, 40.8% were male, 76.5% were black, 50.8% graduated from high school, 26% were married, and 54.1% had income <$5,000. The 8-item medication adherence scale was reliable (alpha=.83) and significantly associated with blood pressure control (P<.05). Using a cutpoint of <6, the sensitivity of the measure to identify patients with poor blood pressure control was estimated to be 93%, and the specificity was 53%. The medication adherence measure proved to be reliable, with good concurrent and predictive validity in primarily low-income, minority patients with hypertension and might function as a screening tool in outpatient settings with other patient groups.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications Inc. (Toronto, Canada )
                1439-4456
                1438-8871
                May 2016
                6 May 2016
                : 18
                : 4
                : e91
                Affiliations
                [1] 1Partners Healthcare Connected Health Boston, MAUnited States
                [2] 2Massachusetts General Hospital Boston, MAUnited States
                [3] 3Harvard Medical School Boston, MAUnited States
                [4] 4Brigham and Women's Hospital Internal Medicine Boston, MAUnited States
                Author notes
                Corresponding Author: Timothy M Hale tmhale@ 123456mgh.harvard.edu
                Author information
                http://orcid.org/0000-0002-4228-465X
                http://orcid.org/0000-0002-0122-8002
                http://orcid.org/0000-0002-1097-5050
                http://orcid.org/0000-0003-1857-0848
                http://orcid.org/0000-0002-7517-2291
                Article
                v18i4e91
                10.2196/jmir.5256
                4890732
                27154462
                62023473-5e91-4a2d-8ca8-17727fe6a6eb
                ©Timothy M Hale, Kamal Jethwani, Manjinder Singh Kandola, Fidencio Saldana, Joseph C Kvedar. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 17.04.2016.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 29 October 2015
                : 26 November 2015
                : 3 February 2016
                : 9 February 2016
                Categories
                Original Paper
                Original Paper

                Medicine
                heart failure,telemonitoring,telehealth,self-management,self-care,complex medication regimens,medication management,medication adherence,hospitalization length of stay,ed visits

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